Prevent from Home: Young person and buddies’ cardiovascuLar heaLth Improvement feasibility Study
The PHYLLIS Study is a pioneering research initiative focused on improving cardiovascular health in postpartum women. Cardiovascular disease is one of the leading causes of preventable deaths in the UK, and women with a history of hypertensive disorders during pregnancy or gestational diabetes are at an increased risk of future heart disease. Unfortunately, ethnic minorities and socioeconomically disadvantaged groups, who are often more affected, are under-represented in research.
This study aims to explore the feasibility of a novel community-based approach that includes postpartum women and their chosen “study buddies”—adult friends or family members who share similar cardiovascular risk factors. By involving peer support, remote monitoring, and home-based testing, the study seeks to create a scalable, culturally appropriate intervention that can engage underserved communities and improve long-term health outcomes.
Patient and Participant InformationFor additional information and contact details for the clinical team, please visit our Patient And Participant Information page |
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Aims
Primary Aim:
- Assess the feasibility of recruiting postpartum women and their study buddies into a trial of a medication called Sodium Glucose Transport Protein-2 Inhibitors (SGLT2i) compared to standard care.
Secondary Aims:
- Explore how to adapt the study for different underserved communities.
- Test the acceptability of involving peer-educator health champions and study buddies.
- Measure changes in key health indicators, such as blood pressure and weight, over time.
Methods
Participants in the PHYLLIS Study include postpartum women with a history of pregnancy-related hypertension or gestational diabetes, and their study buddies (adults aged 18-60 with pre-cardiovascular risk factors). The study involves:
- Regular health checks (blood pressure, weight, and blood tests).
- Remote monitoring using digital tools and home testing kits.
- Peer support through health champions.
Trials Design
This is a Phase II, two-part feasibility trial:
- Part A: Participants are randomised to take either enalapril (a common antihypertensive medication) or another safe medication while breastfeeding.
- Part B: Once breastfeeding ends, participants are randomised to either SGLT2i or standard care for 26 weeks, with ongoing monitoring.
Summary of Findings
Although findings are still being collected, initial feedback indicates that involving study buddies and providing home testing kits has increased participant engagement. The study aims to determine whether these innovative methods can help overcome traditional barriers to healthcare access.
Impact
The PHYLLIS Study has the potential to transform postpartum healthcare by:
- Providing early intervention for women at risk of heart disease.
- Increasing research participation from under-represented communities.
- Offering a model for peer-supported, community-based health programs. If successful, this approach could be scaled up nationally to improve cardiovascular health outcomes for thousands of women and their families.
Our Partners
Principal Investigator
Consultant Nephrologist at King’s College Hospital and Reader at King's College London.
Affiliations
Funding
Funding Body: National Institute for Health Research (NIHR)
Amount: £1,411,334.82
Period: January 2023 - December 2027
Contact us
Contact the study
Email: kch-tr.PhyllisStudy@nhs.net